Sol-Millennium Medical, Inc.

Certificate MDR 766495

Rev. R001Supplemented

Valid until: Nov 7, 2027

Certificate MDR 766495 is a valid Quality management system issued to Sol-Millennium Medical, Inc. and registered in EUDAMED. Valid until November 7, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: MDR 766495
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2797MDR 766495R001

Validity

Issued: Jun 15, 2026
Valid from: Jun 15, 2026
Valid until: Nov 7, 2027

Manufacturer

Manufacturer: Sol-Millennium Medical, Inc.
Manufacturer SRN: US-MF-000010890
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 2797
Notified body country: Netherlands

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

MDR 766495SupplementedApr 16, 2026 → Nov 7, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class I4Class IIa2

6 scopes

Needles for infusion and sampling
Class IIa
Single-use syringes
Class IIa
Needles
Class I
Tubular devices
Class I
Syringes
Class I
Syringes
Class I

Documents

LanguagesEN